Total Quality Senior Specialist jobs in Montana

Total Quality Senior Specialist contributes to the development, implementation, administration and measurement of total quality management programs, including Six Sigma initiatives. Provides expertise to cross functional teams to facilitate total quality methods, training, tool development, and logistical support. Being a Total Quality Senior Specialist coordinates with production, operations, customer service and other functions to implement programs. Typically requires a bachelor's degree. Additionally, Total Quality Senior Specialist typically reports to a manager. The Total Quality Senior Specialist work is highly independent. May assume a team lead role for the work group. A specialist on complex technical and business matters. To be a Total Quality Senior Specialist typically requires 7+ years of related experience. (Copyright 2024 Salary.com)

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Senior Quality Assurance Specialist
  • GSK
  • Hamilton, MT FULL_TIME
  • Site Name: USA - Montana - Hamilton

    Posted Date: Jun 7 2024

    The Senior Quality Assurance Specialist will represent operational QA to ensure the safety, quality and efficacy of product by providing direct support to customers in the production value streams (commercial and product-related), Quality Control, Technical Services (e.g. Facilities, Engineering and Calibration) and the Validation teams. Coaching and Mentoring of site personnel in order to promote a consistent Quality Mindset and understanding of both Patient Safety and Regulatory Compliance will be paramount in this role. The incumbent will support manufacturing operations across two shifts to mimic the Manufacturing schedules and to ensure a consistent Quality Mindset for all teams as GSK Hamilton. There will also be opportunity to support Validation and Qualification activities for new systems, equipment, processes and infrastructure related to adjuvant manufacturing as needed and assigned.

    This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:


    • Quality Systems: may be responsible for management of the following major quality systems: Change control, CAPAs, Deviations. Management of systems includes reporting and training as necessary.
    • Quality: supports GMP compliance and inspection readiness within organization.
    • Investigations: may be responsible for performance, review and approval for investigations associated with complaints, deviations, CAPAs, Out of Specification, Out of Tolerance, Atypical results.
    • QA Validation review: Review validation and qualification documents for QA content, Compliance, and Regulatory impact.
    • Environment Health and Safety: responsible for application of safety and environmental guidelines.
    • Quality and Compliance: execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities.
    • Continuous Improvement: Champion a culture of continuous improvement, and industrial excellence methodologies.
    • Accountability: support employees and respective departments in a manner which is clear in approach, communication and action. Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all matters.


    Why you?

    Basic Qualifications:

    We are looking for professionals with these required skills to achieve our goals:


    • Bachelor's Degree in Scientific Discipline and 3 years of experience in a cGMP regulated environment
    • OR, Associates degree in a scientific field with 5 years pf experience in a cGMP regulated environment with Quality Assurance experience
    • OR, High School Diploma or equivalent with 7 years of experience in a cGMP regulated environment with 3 years as part of the Quality Assurance function


    Preferred Qualifications:


    • Bachelor’s Degree with specialization in Computer Validation or QA for Computerized Systems 5 years experience in cGMP pharmaceutical environment or related industry focused on quality operations
    • Demonstrated experience and working knowledge of cGMPs and associated regulatory requirements and guidelines for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products required.
    • Significant understanding of US and European GMP regulations.
    • Strong verbal and written communication skills.
    • Ability to work successfully both independently and in a team environment.
    • Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.
    • Use and understanding of SAP system.
    • Microbiology Background
    • Chemistry Background Automation
    • Automation Engineering Experience


    Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

    Why GSK?

    Uniting science, technology and talent to get ahead of disease together.

    GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

    Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).

    GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

  • 2 Days Ago

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Senior Quality Assurance Specialist
  • GlaxoSmithKline
  • Hamilton, MT FULL_TIME
  • Site Name: USA - Montana - HamiltonPosted Date: Jun 7 2024The Senior Quality Assurance Specialist will represent operational QA to ensure the safety, quality and efficacy of product by providing direc...
  • Just Posted

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Senior Quality Assurance Specialist - 2nd Shift
  • GlaxoSmithKline
  • Hamilton, MT FULL_TIME
  • Site Name: USA - Montana - HamiltonPosted Date: May 14 2024The Senior Quality Assurance Specialist - 2nd Shift will represent operational QA to ensure the safety, quality and efficacy of product by pr...
  • 26 Days Ago

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Senior Quality Assurance Specialist - 2nd Shift
  • GSK
  • Hamilton, MT FULL_TIME
  • Site Name: USA - Montana - HamiltonPosted Date: May 15 2024The Senior Quality Assurance Specialist - 2nd Shift will represent operational QA to ensure the safety, quality and efficacy of product by pr...
  • Just Posted

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Quality Assurance Specialist I
  • Rocky Mountain Biologicals
  • Missoula, MT FULL_TIME
  • Quality Assurance Specialist I Full time 40 hrs/week MUST BE LEGALLY AUTHORIZED TO WORK IN THE US. VISA SPONSORSHIP IS NOT OFFERED. RELOCATION ASSISTANCE IS NOT PROVIDED. Company Overview: Rocky Mount...
  • 5 Days Ago

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Quality Assurance Specialist
  • Wyo-Ben, Inc.
  • Billings, MT FULL_TIME
  • No recruiters or unsolicited agency referrals please. Wyo-Ben Pet is a new division of Wyo-Ben Inc. where we focus on the packaging of clumping cat litter. Wyo-Ben Pet’s new facility uses state-of-the...
  • 25 Days Ago

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Quality Specialist
  • Flatiron Construction Corp
  • Concord, CA
  • Come join our NorCal team (Bay Area/Sacramento) as a Quality Specialist! A great opportunity to join an industry-leading...
  • 6/11/2024 12:00:00 AM

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Quality Specialist
  • Independence Blue Cross
  • Philadelphia, PA
  • Job Summary Responsibility for completing accuracy reviews of case samples for program audits. Assesses operational and ...
  • 6/11/2024 12:00:00 AM

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Quality Specialist
  • D&W
  • Elk Grove Village, IL
  • We have an immediate opportunity for a Quality Technician with SQF, HACCP, Food Safety program knowledge and experience....
  • 6/11/2024 12:00:00 AM

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Assistant Quality Manager
  • Gestamp
  • Mason, TX
  • Role Summary The Assistant Quality Manager is responsible for the support of the Quality Manager in evaluation, benchmar...
  • 6/9/2024 12:00:00 AM

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Quality Specialist
  • Abb Holdings Inc
  • Florence, SC
  • Quality Specialist Take your next career step at ABB with a global team that is energizing the transformation of society...
  • 6/9/2024 12:00:00 AM

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Assistant Quality Manager
  • Fowler Packing Company
  • Fresno, CA
  • Located in Fresno, California, Flower Packing Company is the parent company to some of the industry’s most popular brand...
  • 6/8/2024 12:00:00 AM

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Assistant Quality Manager
  • Hiring Now!
  • La Grange, TX
  • Job Description We are seeking a highly qualified Assistant Quality Manager. The ideal candidate will have a four-year d...
  • 6/8/2024 12:00:00 AM

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Quality Specialist
  • ABB
  • Florence, SC
  • Take your next career step at ABB with a global team that is energizing the transformation of society and industry to ac...
  • 6/7/2024 12:00:00 AM

Montana (/mɒnˈtænə/ (listen)) is a landlocked state in the Northwestern United States. Montana has several nicknames, although none are official, including "Big Sky Country" and "The Treasure State", and slogans that include "Land of the Shining Mountains" and more recently "The Last Best Place". Montana is the 4th largest in area, the 8th least populous, and the 3rd least densely populated of the 50 U.S. states. The western half of Montana contains numerous mountain ranges. Smaller island ranges are found throughout the state. In all, 77 named ranges are part of the Rocky Mountains. The easte...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Total Quality Senior Specialist jobs
$105,849 to $125,959

Total Quality Senior Specialist in Columbia, SC
Likely to be either a specialist within a particular focus area for QHSE, e.g., environmental, transportation, training, etc., or is based at a specific location in a generalized role.
February 18, 2020